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Mako Surgical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
34
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260222Mako Total Knee ApplicationFebruary 25, 2026
K250608Mako Total Knee Application (3.0); Hybrid Tip PointerApril 25, 2025
K243751Mako Total Hip Application 5.0March 5, 2025
K242373Mako Shoulder Application (1.0)November 7, 2024
K241011Mako Total Knee ApplicationJune 11, 2024
K220930Restoris Multi-Compartmental Knee SystemJune 2, 2022
K220459Mako Total Knee ApplicationApril 15, 2022
K193515Mako Total Knee ApplicationJuly 14, 2020
K193128Mako Total Hip ApplicationFebruary 2, 2020
K191998Mako Total Hip Application, Mako Total Knee ApplicationSeptember 24, 2019
K172301Mako Partial Knee ApplicationNovember 2, 2017
K172219Mako Total Knee ApplicationSeptember 21, 2017
K170891Mako Partial Knee ApplicationMay 24, 2017
K170584Mako Partial Knee ApplicationMay 11, 2017
K170581Mako Total Knee ApplicationMay 11, 2017
K170593Mako Total Hip ApplicationApril 18, 2017
K143752Total Knee Application (TKA)August 6, 2015
K150307RESTORIS Multicompartmental Knee SystemMarch 10, 2015
K143635KINETIS Total Knee SystemFebruary 20, 2015
K142606Trident® Tritanium® PST® Acetabular ShellsJanuary 26, 2015